A Phase 3, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of two dose levels of BCX7353 as an oral treatment for the prevention of attacks in subjects with hereditary angioedema
Status: Active, no longer recruiting
Phase of Trial: Phase III
Latest Information Update: 05 Nov 2019
Price : $35 *
At a glance
- Drugs Berotralstat (Primary)
- Indications Hereditary angioedema
- Focus Registrational; Therapeutic Use
- Acronyms APeX-J
- Sponsors BioCryst Pharmaceuticals
- 05 Nov 2019 According to a BioCryst Pharmaceuticals media release, BioCryst plans to submit a Japanese New Drug application (JNDA) to the Pharmaceuticals and Medical Devices Agency (PMDA) in the first quarter of 2020.
- 06 Aug 2019 Planned End Date changed from 1 May 2020 to 1 Jun 2020.
- 06 Aug 2019 Planned primary completion date changed from 1 Oct 2019 to 1 Nov 2019.